title: Evidence based herbal drug standardization approach in coping with challenges of holistic management of diabetes: a dreadful lifestyle disorder of 21st century.
abstract: Plants by virtue of its composition of containing multiple constituents developed during its growth under various environmental stresses providing a plethora of chemical families with medicinal utility. Researchers are exploring this wealth and trying to decode its utility for enhancing health standards of human beings. Diabetes is dreadful lifestyle disorder of 21st century caused due to lack of insulin production or insulin physiological unresponsiveness. The chronic impact of untreated diabetes significantly affects vital organs. The allopathic medicines have five classes of drugs, or otherwise insulin in Type I diabetes, targeting insulin secretion, decreasing effect of glucagon, sensitization of receptors for enhanced glucose uptake etc. In addition, diet management, increased food fiber intake, Resistant Starch intake and routine exercise aid in managing such dangerous metabolic disorder. One of the key factors that limit commercial utility of herbal drugs is standardization. Standardization poses numerous challenges related to marker identification, active principle(s), lack of defined regulations, non-availability of universally acceptable technical standards for testing and implementation of quality control/safety standard (toxicological testing). The present study proposed an integrated herbal drug development & standardization model which is an amalgamation of Classical Approach of Ayurvedic Therapeutics, Reverse Pharmacological Approach based on Observational Therapeutics, Technical Standards for complete product cycle, Chemi-informatics, Herbal Qualitative Structure Activity Relationship and Pharmacophore modeling and, Post-Launch Market Analysis. Further studies are warranted to ensure that an effective herbal drug standardization methodology will be developed, backed by a regulatory standard guide the future research endeavors in more focused manner.
authors.affiliation: Office of CC R&D (LS & IC), Defence Research and Development Organisation, DRDO Bhawan, New Delhi, India. rajesharoradr@gmail.com.
authors.forename: Raman
authors.initials: R
authors.lastname: Chawla
authors.forename: Pallavi
authors.initials: P
authors.lastname: Thakur
authors.forename: Ayush
authors.initials: A
authors.lastname: Chowdhry
authors.forename: Sarita
authors.initials: S
authors.lastname: Jaiswal
authors.forename: Anamika
authors.initials: A
authors.lastname: Sharma
authors.forename: Rajeev
authors.initials: R
authors.lastname: Goel
authors.forename: Jyoti
authors.initials: J
authors.lastname: Sharma
authors.forename: Smruti Sagar
authors.initials: SS
authors.lastname: Priyadarshi
authors.forename: Vinod
authors.initials: V
authors.lastname: Kumar
authors.forename: Rakesh Kumar
authors.initials: RK
authors.lastname: Sharma
authors.forename: Rajesh
authors.initials: R
authors.lastname: Arora